Impact of Noninvasive Telemonitoring on Clinical Events, Healthcare Resource Use and Costs in Heart Failure

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to know if telemonitoring and telematic follow-up reduces the healthcare resources utilization, healthcare costs and non-healthcare costs of patients with high-risk heart failure. The main questions it aims to answer are: * Does telematic follow-up reduce de use of healthcare resource utilization of patients with heart failure? * Is telematic follow-up cost-efficient in terms of reducing direct healthcare costs in heart failure patients? * Is telematic follow-up cost-efficient in terms of reducing non-healthcare costs in heart failure patients? Participants will be randomized to usual care (control group) or telematic care (interventional group). Patients randomized to the interventional group will be included in a protocol of daily automatic telemonitoring of arterial pressure, peripheral oximetry, heart rate and weight, and telematic consultations lead by a heart failure clinical specialized team. Researchers will compare the healthcare resource utilization, healthcare and non-healthcare costs of patients randomized to control vs. interventional group.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of HF according to the 2021 guidelines of the European Society of Cardiology criteria for ≥3 months.

• Admitted for decompensation of chronic HF.

• Admitted for HF decompensation ≥30 days and ≤6 months.

• HF decompensation in ≥30 days and ≤6 months but discharged directly from the emergency department or managed on an outpatient basis, but requiring intravenous diuretic administration in an ambulatory basis, or \>50% increase in loop diuretic dose.

• With previous optimized prognostic medical treatment.

• Under treatment with loop diuretic drugs.

• New York Heart Association functional class II, III or IV.

Locations
Other Locations
Spain
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Contact Information
Primary
Juan Carlos López-Azor García, MD, PhD
lopez.gcia.juan.carlos@gmail.com
+34628026462
Time Frame
Start Date: 2023-11-29
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 390
Treatments
Experimental: Telemonitoring group
Follow-up group by telematic consultations and non-invasive daily telemonitoring of weight, blood pressure, heart rate, peripheral oxygen saturation and electrocardiogram.
No_intervention: Control gropu
Usual care follow-up group
Related Therapeutic Areas
Sponsors
Leads: Hospital Universitario 12 de Octubre
Collaborators: Consorcio Centro de Investigación Biomédica en Red (CIBER), Hospital Universitario Puerta de Hierro de Majadahonda, Fundacion Investigacion Biomedica Hospital 12 de Octubre

This content was sourced from clinicaltrials.gov